BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO

    MDR report key: 11742127 · Received April 28, 2021

    Report

    Report Number
    3006695864-2021-07582
    Event Type
    Injury
    Date Received
    April 28, 2021
    Report Date
    May 7, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K151636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. TREND ANALYSIS AND THE DOCUMENTATION/LABEL REVIEW: THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THE DOCUMENTATION/LABEL REVIEW DEFINES POTENTIAL COMPLICATIONS AND ADVERSE EVENTS ASSOCIATED WITH THIS TYPE OF SURGERY. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THE ISSUES EVALUATED IN THIS INVESTIGATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION AND BASED ON LIMITED INFORMATION AVAILABLE, IT CANNOT BE DETERMINED IF THERE IS A PRODUCT MALFUNCTION AS NO DEVICE FAILURE WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN AS IT WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. MANUFACTURER DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Description of Event or Problem · 1

    THE FOLLOWING WAS RECEIVED BASED ON A CLINICAL STUDY FROM A RESEARCH INSTITUTION: STUDY NAME: A COMPARISON OF VENTURI AND PERISTALTIC BASED PHACOEMULSIFICATION IN FEMTOSECOND LASER CATARACT SURGERY. A RESEARCH INSTITUTE REPORTED A PATIENT WAS DIAGNOSED WITH CYSTOID MACULAR EDEMA FOLLOWING CATARACT SURGERY WHEN USING THE CATALYS SYSTEM FEMTOSECOND LASER AND WHITESTAR SIGNATURE PRO PHACOEMULSIFICATION SYSTEM. DESCRIPTION OF EVENT: A RESEARCH INSTITUTE REPORTED A PATIENT WAS DIAGNOSED WITH CYSTOID MACULAR EDEMA FOLLOWING CATARACT SURGERY WHEN USING THE CATALYS SYSTEM FEMTOSECOND LASER AND WHITESTAR SIGNATURE PRO PHACOEMULSIFICATION SYSTEM. AT A ONE-MONTH POST OP EXAM, THE PATIENT RETURNED TO REFERRING OPTOMETRIST WITH EDEMA AND WORSENING VISION. AT THAT TIME, THE PATIENT WAS PRESCRIBED STEROID DROPS TO RESOLVE SYMPTOMS. AT A 3-MONTH POST OP EXAM, THE VISION HAD DETERIORATED FURTHER. THE PATIENT WAS PRESCRIBED BROMSITE AND PREDNSOLONE EYE DROPS AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). THE PATIENT WAS SCHEDULED TO RETURN TO CLINIC IN 3 WEEKS. ADDITIONAL NARRATIVE FROM THE CLINIC: THIS IS A DESCRIBED COMPLICATION/RISK FOR CATARACT SURGERY AND IS LIKELY NOT RELATED TO THE RESEARCH STUDY. THIS SUBJECT¿S CONDITION WAS ACCELERATED DUE TO HIM NOT FILLING THE STEROID PRESCRIPTION AFTER SEEING HIS REFERRING OPTOMETRIST. OUTCOME: ONGOING / CONTINUING TREATMENT: IT WAS REPORTED THE EVENT INTERRUPT A PARTICIPANT¿S USUAL DAILY ACTIVITY AND MAY REQUIRE SYSTEMIC DRUG THERAPY OR OTHER TREATMENT. AS OF (B)(6) OUTCOME PATIENT RECEIVED SUBTENON KENALOG INJECTION IN BOTH EYES FOR CME(CYSTOID MACULAR EDEMA). TODAY¿S (OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SLIGHT IMPROVEMENT COMPARED TO PREVIOUS STUDY RELATIONSHIP TO STUDY INTERVENTION: NOT RELATED: THERE IS NOT A REASONABLE POSSIBILITY THAT THE ADMINISTRATION OF THE STUDY INTERVENTION CAUSED THE EVENT, THERE IS NO TEMPORAL RELATIONSHIP BETWEEN THE STUDY INTERVENTION AND EVENT ONSET, OR AN ALTERNATE ETIOLOGY HAS BEEN ESTABLISHED. EXPECTEDNESS BASED FROM THE RESEARCH STUDY: EXPECTED. THIS REPORT IS FOR THE SIGNATURE PRO EQUIPMENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE CATALYS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634697 WHITESTAR SIGNATURE PRO UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680301

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention CATALYS SYSTEM SERIAL NO.(B)(4).